プロフィール詳細

プロジェクトを作成

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Dr. Mohamad T.に依頼

Germany

Specialist in Cell and Gene Therapy manufacturing | Tissues Engineering | Analytical Development | Process Development

プロフィール概要

I provide specialized consulting services to pharmaceutical and medical device companies with a focus on GMP compliance, CMC development, quality control, and manufacturing science. With over a decade of experience across small molecules, biologics, mRNA therapies, ADCs, and vaccines, I support companies in navigating complex technical and regulatory challenges across the entire product lifecycle—from early development to commercial manufacturing. My core expertise lies in identifying and solving problems that impact product quality, regulatory compliance, and production timelines. I work directly with internal teams or contract manufacturers (CDMOs) to assess gaps, implement GMP-compliant systems, and prepare for audits and submissions. 🔧 What I Do GMP Compliance & Risk Management → Support with deviation investigations, CAPA systems, audit preparation, and inspection readiness. CMC Strategy & Documentation → Design and review CMC sections for clinical and marketing submissions (IMPD, IND, BLA, NDA). Analytical & QC Support → Method development, qualification, validation, and reference material lifecycle management. Tech Transfer & Process Validation → Ensure smooth transfer of manufacturing and testing processes to GMP facilities, including site readiness and equipment qualification. Stability & Reference Standards → Develop stability protocols, assess reference material suitability, and manage trending and out-of-spec investigations. 🔍 Who I Work With Pharmaceutical manufacturers (R&D to commercial) Biotech startups developing mRNA, cell & gene therapies, ADCs Contract Development & Manufacturing Organizations (CDMOs) Quality and regulatory teams under pressure to meet deadlines or fix compliance issues 🚀 Value I Bring Rapid problem-solving of non-compliance, process gaps, or failing validation studies Hands-on experience working with regulators and GMP inspectors Cross-functional leadership in tech transfer and late-phase manufacturing readiness Strong understanding of both scientific details and regulatory expectations

専門分野

• ★ Pharmaceutical Process Development
• ★ Pharmaceutical Technology
• ★ CMC Documentation
• ☆ Molecular Modeling
• ☆ Stem Cell Research
• ☆ Biotechnology & Bioengineering
• ☆ Data Analysis
• ☆ Artificial Intelligence
• ☆ Artificial Organs
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Clinical Biochemistry
• ☆ Tissue Microarray
• ☆ Gene Therapy
• ☆ Pharmaceutical Management
• ☆ Product Validation
• ☆ Regulatory Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Newswriting

Research Market Research, User Research, Meta-Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis, Algorithm Design-Non ML, Algorithm Design-ML, Data Visualization, Big Data Analytics, Text Mining & Analytics, Data Mining, Data Processing

Product Development Formulation, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Prototyping, Device Fabrication

職務経験

Head of research and development

Molgenium

1月 2019 - 現在

CSO

Molgenium

1月 2019 - 現在

Postdoct researcher

University of Hannover

2月 2017 - 12月 2018

学歴

Doctor of Philosophy (Ph.D)

Heinrich Heine University

1月 2014 - 1月 2017

PhD (Biochemistry - Cell Biology )

Tierärztliche Hochschule Hannover

1月 2014 - 12月 2016

認定資格

• GMP manager

  LVQ

  8月 2019 - 現在

• Cell Therapy

  FAU Erlangen

  8月 2016 - 現在

出版物

JOURNAL ARTICLE

Mohamad Touotunji, Dalanda Wanes, Mohammad El-Harakeh, Marwan El-Sabban, Sandra Rizk, Hassan Naim (2020). Dextran Sodium Sulfate-Induced Impairment of Protein Trafficking and Alterations in Membrane Composition in Intestinal Caco-2 Cell Line . International Journal of Molecular Sciences.

Wanes,D.;Toutounji,M.; Sebai, H.; Rizk, S.; Naim, H.Y .